title: Repeated dose toxicity study of Vibrio cholerae-loaded gastro-resistant microparticles.
abstract: BACKGROUND
  Microencapsulation of antigens has been extensively studied over the last decades aiming at improving the immunogenicity of vaccine candidates.
  
  
  OBJECTIVE
  Addressing microparticles (MPs) toxicity in rats.
  
  
  METHODS
  Spray-dried Eudragit® L 30 D-55 MPs and Eudragit® L 30 D-55 alginate MPs were elaborated and characterized. MPs obtained were administered to rats, three groups were defined: G1, control group; G2, administered with Vibrio cholerae (VC)-loaded MPs; G3, receiving VC-loaded alginate MPs. Animals received three vaccine doses. Body weight, food and water intake were controlled during the study. Haematological parameters, vibriocidal titres, organ weight and histology in necropsy were also analyzed.
  
  
  RESULTS
  All animals grew healthy. Body weight gain, food and water intake and haematological parameters remained within physiological values, showing no treatment-related differences. Moreover, organ weight changes were not detected and animals developed protective vibriocidal titres.
  
  
  CONCLUSIONS
  VC-loaded MPs and VC-loaded alginate MPs have proved to be safe and effective in the assessed conditions.
authors.affiliation: Finlay Institute, Centro de Investigación-Producción de vacunas y sueros , 27 Avenue No. 19805, La Lisa, Ciudad de la Habana, A.P. 16017, Cod. 11600 , Cuba .
authors.forename: Yulieé
authors.initials: Y
authors.lastname: López
authors.forename: Marta
authors.initials: M
authors.lastname: Pastor
authors.forename: Juan Francisco
authors.initials: JF
authors.lastname: Infante
authors.forename: Daiyana
authors.initials: D
authors.lastname: Díaz
authors.forename: Reynaldo
authors.initials: R
authors.lastname: Oliva
authors.forename: Sonsire
authors.initials: S
authors.lastname: Fernández
authors.forename: Bárbara
authors.initials: B
authors.lastname: Cedré
authors.forename: Tamara
authors.initials: T
authors.lastname: Hernández
authors.forename: Longeia
authors.initials: L
authors.lastname: Campos
authors.forename: Amaia
authors.initials: A
authors.lastname: Esquisabel
authors.forename: José Luis
authors.initials: JL
authors.lastname: Pedraz
authors.forename: Viviana
authors.initials: V
authors.lastname: Perez
authors.forename: Arturo
authors.initials: A
authors.lastname: Talavera
mesh_terms: D000818:Animals; D002214:Capsules; D002771:Cholera / Q000517:prevention & control; D022121:Cholera Vaccines / Q000009:adverse effects / Q000737:chemistry / Q000494:pharmacology; D004305:Dose-Response Relationship, Drug; D016503:Drug Delivery Systems / Q000009:adverse effects*; D008297:Male; D011109:Polymethacrylic Acids / Q000009:adverse effects / Q000737:chemistry; D051381:Rats; D017207:Rats, Sprague-Dawley; D014734:Vibrio cholerae
chemical_list: D002214:Capsules; D022121:Cholera Vaccines; D011109:Polymethacrylic Acids; C038300:methylmethacrylate-methacrylic acid copolymer